Treating Intrabony Defect With MINST VS MINST Extended PRF (MINST PRF)
Clinical Effectiveness of Minimally Invasive Non-surgical Technique With or Without Extended Platelets Rich Fibrin in Intrabony Defects: a Randomized Controlled Clinical Trial
This study evaluates a minimally invasive non-surgical technique (MINST) for treating periodontal intrabony defects, with or without the addition of Extended Platelet-Rich Fibrin (e-PRF). The goal is to determine which approach provides better bone regeneration and gum healing.
Study Procedures
Control Group:
Local anesthesia by infiltration at the treatment site
Instrumentation of the root surface up to the bottom of the periodontal pocket
Efforts are made to minimize trauma to soft tissues and interdental papilla using subpapillary access
Cleaning is performed using piezo-electric devices with delicate tips, avoiding aggressive root smoothing or gingival curettage
3-4× magnification loupes are used to improve precision
Intervention Group:
All the above procedures
Followed by injection of e-PRF, a preparation derived from the patient's own blood
Blood is collected in 4 mL tubes and centrifuged at 700 g for 8 minutes
The platelet-poor plasma is heated to create an albumin gel
The remaining buffy coat (rich in platelets and growth factors) is mixed with the cooled albumin gel to form Alb-PRF, which is applied to the defect
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Samuel Michael Mikhail, B.Sc.
- Номер телефона: +201117776200
- Электронная почта: samuel.girgis@dentistry.cu.edu.eg
Места учебы
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Giza Governorate
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Giza, Giza Governorate, Египет, 12613
- Рекрутинг
- Faculty of Dentistry, Cairo University
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Контакт:
- Samuel Mikhail, B.Sc.
- Номер телефона: +201117776200
- Электронная почта: samuel.girgis@dentistry.cu.edu.eg
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Adults aged above 21 years. Clinical diagnosis of Stage III periodontitis. Presence of at least two isolated interproximal intrabony defects located in different quadrants.
Intrabony defect associated with a single-rooted tooth or mandibular molar without furcation involvement.
Probing depth (PD) ≥ 6 mm. Radiographic intrabony defect depth between 3 and 7 mm. Absence of periapical pathology at the study site. Absence of acute periodontal infection. Absence of subgingival restorations that could interfere with clinical measurements.
Absence of Grade II or Grade III tooth mobility. Ability and willingness to provide written informed consent.
Exclusion Criteria:
Pregnancy or lactation. Non-surgical periodontal therapy within the previous 6 months. Surgical periodontal therapy within the previous 12 months. History of radiotherapy to the head and neck region. Current smoking.
Eligibility note: Former smokers and never-smokers are eligible.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: MINST Alone
Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) alone. The procedure will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. No platelet-rich fibrin or other regenerative biomaterial will be applied. |
Modified minimally invasive non-surgical periodontal therapy performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes. The procedure aims to thoroughly debride the periodontal pocket while minimizing soft tissue trauma and preserving root cementum by avoiding intentional root surface smoothing and gingival curettage. |
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Экспериментальный: MINST + Extended Platelet-Rich Fibrin (e-PRF)
Participants will receive modified minimally invasive non-surgical periodontal therapy (MINST) followed by the application of autologous extended platelet-rich fibrin (e-PRF) into the intrabony periodontal defect. MINST will be performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes while preserving root cementum and minimizing soft tissue trauma. The e-PRF will be prepared from the participant's peripheral blood by combining heated albumin gel with liquid platelet-rich fibrin before placement into the defect. The protocol follows the procedures described in the study protocol |
Modified minimally invasive non-surgical periodontal therapy performed under local anesthesia using piezoelectric ultrasonic instruments with thin tips and magnification loupes. The procedure aims to thoroughly debride the periodontal pocket while minimizing soft tissue trauma and preserving root cementum by avoiding intentional root surface smoothing and gingival curettage. Autologous extended platelet-rich fibrin (e-PRF) prepared from the participant's peripheral blood. Whole blood is centrifuged to obtain liquid platelet-rich fibrin, while the platelet-poor plasma is heated to form denatured albumin gel. The cooled albumin gel is mixed with the liquid platelet-rich fibrin to produce e-PRF, which is applied into the periodontal intrabony defect immediately after completion of the MINST procedure |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in Probing Depth (PD)
Временное ограничение: Baseline and 6 months after treatment
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Change in periodontal probing depth (PD), measured in millimeters using a UNC-15 periodontal probe with a standardized probing force. Measurements are obtained using a patient-specific acrylic stent to ensure reproducibility. |
Baseline and 6 months after treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Clinical Attachment Level (CAL)
Временное ограничение: Baseline, 3 months, and 6 months after treatment
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Baseline, 3 months, and 6 months after treatment
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Change in Gingival Recession (GR) measured using a UNC-15 periodontal probe
Временное ограничение: Baseline, 3 months, and 6 months after treatment
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Baseline, 3 months, and 6 months after treatment
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Change in Radiographic Intrabony Defect Depth measured using standardized periapical radiographs and ImageJ software
Временное ограничение: Baseline and 6 months after treatment
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Baseline and 6 months after treatment
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Patient Satisfaction (VAS)
Временное ограничение: During the first postoperative week after treatment
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0 indicates no pain or discomfort and 10 indicates the worst imaginable pain or discomfort. |
During the first postoperative week after treatment
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Fujioka-Kobayashi M, Schaller B, Mourao CFAB, Zhang Y, Sculean A, Miron RJ. Biological characterization of an injectable platelet-rich fibrin mixture consisting of autologous albumin gel and liquid platelet-rich fibrin (Alb-PRF). Platelets. 2021 Jan 2;32(1):74-81. doi: 10.1080/09537104.2020.1717455. Epub 2020 Jan 20.
- Miron RJ, Pikos MA, Estrin NE, Kobayashi-Fujioka M, Espinoza AR, Basma H, Zhang Y. Extended platelet-rich fibrin. Periodontol 2000. 2024 Feb;94(1):114-130. doi: 10.1111/prd.12537. Epub 2023 Nov 20.
- Ribeiro FV, Mehta JJ, Monteiro MF, Moore J, Casati MZ, Nibali L. Minimal invasiveness in nonsurgical periodontal therapy. Periodontol 2000. 2023 Feb;91(1):7-19. doi: 10.1111/prd.12476. Epub 2023 Jan 20.
- Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.
- Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- Ext-prf-defect
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, baseline clinical measurements, outcome measures, and follow-up data.
Сроки обмена IPD
Start: 6 months after publication of the primary results End: 5 years after publication of the primary results
Критерии совместного доступа к IPD
De-identified individual participant data, the study protocol, the statistical analysis plan, and the informed consent form will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the Principal Investigator. Access will be provided after review and approval of the proposal and execution of a data use agreement, with data shared in a secure electronic format.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .